Recruiting

Artacent™

Sponsor:

Tides Medical

Code:

NCT02838784

Conditions

Venous Ulcer

Foot Ulcer, Diabetic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Artacent Human Amniotic Membrane

Standard of Care

Study Details

Brief summary:

This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey

Conditions

Venous Ulcer

Foot Ulcer, Diabetic

Study ID

NCT02838784

Start date

Sep, 2016

Status verified date

Oct, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18 years or older
  • Able and willing to give consent and to comply with study
  • Lower extremity ulcer between 1 and 25 cm2 point after the 4 week run-in period
  • Has received documented SOC treatment for 4 weeks or greater duration resulting in <50% reduction in the ulcer size
  • No clinical signs of infection at the ulcer site
  • Serum Creatinine below 3.0 mg/dl
  • Serum HgA1c below 12%
  • Adequate circulation to the affected limb with ABI between 0.7 and 1.2 or tri-/bi-phasic arterial waveforms at the ankle of the affected leg.

Exclusion Criteria:

  • Is participating in another wound study
  • Has a Charcot foot
  • Has previously received a different biological graft on the target foot
  • Has more than one lower extremity ulcer
  • Has an ulcer that probes to bone or involves tendon, muscle, joint capsule or has sinus tracts
  • Is currently receiving radiation or chemotherapy
  • Has an autoimmune connective tissue disorder
  • Is taking any medication known to be an immune system modulator
  • Is pregnant or is considering becoming pregnant within the next 6 months

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Artacent Human Amniotic Membrane

Patients randomized to the Artacent group will receive standard of care (off-loading with a removable cast walker and non-adherent dressings in addition to debridement and use of moisture retentive dressing) and the application of the Artacent amniotic allograft once every two weeks for up to 5 applications or until the ulcer has healed.

active comparator: Lower Extremity Ulcer Standard of Care

Patients randomized to standard of care will receive off-loading with a removable cast walker and non-adherent dressings (e.g. Adaptic) in addition to debridement and use of moisture retentive dressings. An outer dressing will also be applied.

Interventions

Artacent Human Amniotic Membrane

Double layer dehydrated amnion product

Standard of Care

Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings

Primary outcome measure

  • Wound closure [ Time Frame: 12 weeks ]
  • Time to wound closure [ Time Frame: 12 weeks ]
  • Ulcer recurrence [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Abigail Allen

aallen@mcra.com

Nancy Malchoff

6466733133nmalchoff@mcra.com

Locations

Global Podiatry Partners, Inc

Recruiting

Arcadia, California, United States, 91007

Contacts

Wenjay Sung, DPM

626-275-2195

Amy Keyzer

626-275-2195

Iberia Medical Center

Recruiting

New Iberia, Louisiana, United States, 70560

Contacts

Michelle Menard, DPM

337-367-0271

Brandi Angelle

337-367-0271

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Noah Oliver, DPM

504-842-8751

Terri Lopez

504-842-8751

Livingston Podiatry Associates PLLC

Recruiting

Bellmore, New York, United States, 11710

Contacts

Michael Livingston, DPM

516-308-4500

Donna Knepple

516-308-4500

Foot & Ankle Physicians of Ohio

Recruiting

Grove City, Ohio, United States, 43123

Contacts

Elizabeth Hewitt, DPM

614-782-3668

Tracy Perez

614-782-3668

Southwest Austin Foot & Ankle Clinic, PLLC

Recruiting

Austin, Texas, United States, 78735

Contacts

Mark Whitesides, DPM

512-447-4122

Cindy Whitesides

512-447-4122

More Information

Sponsor

Tides Medical

Last update posted

Oct 13, 2017

Last verified

Oct, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tides Medical on 2017-10-13.